European Journal of Biomedical and Pharmaceutical Sciences

MEDICAL DEVICES

Rushikesh Ghule*, Anjali Kadam, Sumit Kapadnis, Sarvesh bhoomkar, S. A. Waghmare and Hemant Kamble

ABSTRACT

Medical devices are important to provide health care and to improve the health of individuals and populations. The World Health Organization (WHO) recognizes this. One of WHO’s strategic objectives is to ensure improved access, quality and use of medical devices. Without medical devices, routine medical procedures—from bandaging a sprained ankle, to diagnosing HIV/AIDS or implanting an artificial hip—would be impossible. Concurrently, modern technology is producing an overwhelming abundance of medical devices at a rate that soon makes the latest device obsolete. Key issues affecting progress include the extreme diversity of the medical device arena—diverse in terms of types of devices, degrees of complexity, applications, usage, users and categories and issues like the context dependency of medical devices and research in medical devices often not based on public health needs. Medical devices are becoming more important in the health care unit. Diversity and intricacy of medical devices in last two decades. Regulation of these devices has also advanced due to the requirement for a steady regulatory perspective. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. the design of medical devices and investigate its relationship among different factors that must be taken into consideration throughout the process. The theoretical foundation of this paper was formed by conducting a comprehensive literature review on medical device design.

Keywords: Medical devices, Medical Device Design, Medical device regulations, The medical device market.